The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
NCT Number: NCT01930370
Modeling of bicarbonate within the dialysate fluid, specifically a lower than standard concentration has been suggested in facilitating the removal of phosphate and potassium. To test this hypothesis, the study will use a cross-over study design to evaluate phosphate and potassium removal during dialysis by altering bicarbonate concentration in dialysis fluid (i.e. high bicarbonate, standard bicarbonate washout, low bicarbonate), and compare the effects of the different dialysate bicarbonate concentrations on the removal of phosphate and potassium during hemodialysis
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Notify MeUp to 18 year
All sexes
Interventional
Phase 4
Toronto, Ontario, M5G 1X8, Canada
Elevation of blood phosphate levels in chronic dialysis patients is associated with increased mortality due to cardiovascular events, and if sustained leads to hyperactivity of parathyroid glands and renal bone disease. Similarly, increased calcium-phosphate product as a result of elevated levels of phosphate in the blood is an additional risk factor for vascular calcification. Elevated blood potassium levels is another major electrolyte disorder in patients with advanced renal disease which is potentially life threatening. Therefore control of blood phosphate and potassium levels is a fundamental component of treatment for end stage renal disease. Management of hyperelectrolyte levels in renal failure patients requires restriction of phosphate and potassium intake through dietary measures, promotion of excretion via GI tract through medication delivery (i.e. supplementary binders), and removal through dialysis. All these strategies come with limitations however, specifically adherence to dietary restrictions and medication compliance is poor due to lack of immediate repercussions, as well as the complex kinetics involved with removal via dialysis given the dependence on duration and frequency of dialysis whose manipulation is limited by time considerations for the patient and scheduling issues in the dialysis unit.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One-week experimental session (3 dialysis treatments) with low dialysate bicarbonate (28 mmol/L)
One-week experimental session with high dialysate bicarbonate (38 mmol/L)
Time frame: Dialysis Treatment 1 (Day 1) - Pre and Post dialysis (0hrs and 4hours)
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):
Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
Time frame: Dialysis Treatment 2 (Day 2) - Pre and Post dialysis (0hrs and 4hours)
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):
Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
Time frame: Dialysis Treatment 3 (Day 3) - Pre and Post dialysis (0hrs, 4hours, 5hours)
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):
Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
Time frame: Dialysis Treatment 7 (Day 15) - Pre and Post dialysis (0hrs, 4hours)
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):
Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
Time frame: Dialysis Treatment 8 (Day 16) - Pre and Post dialysis (0hrs, 4hours)
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):
Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
Time frame: Dialysis Treatment 9 (Day 17) - Pre and Post dialysis (0hrs, 4hours, 5hours)
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):
Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
Time frame: Baseline and Post Dialysis (4hours)
Measurement of the biochemical (serum) parameters of Phosphate for each dialysis treatment
Time frame: Pre and Post Dialysis
Measurement of the biochemical (serum) parameters of Potassium for each dialysis treatment
Time frame: Pre and Post Dialysis (0 and 4hours)
Measurement of the biochemical (serum) parameters of CO2 (bicarbonate) for each dialysis treatment
Time frame: Pre and Post Dialysis (0 and 4hours)
Biochemical measurement of the blood for corrected caclium (calcium and albumin) for each dialysis treatment
Time frame: Pre and Post Dialysis (0 and 4hours)
Measurement of Blood urea will be performed for each dialysis treatment.
Time frame: Pre and Post Dialysis (0 and 4hours)
Measurement of Blood urea will be performed for each dialysis treatment.
The Hospital for Sick Children
Other
Effect of Varied Dialysate Bicarbonate Levels on Phosphate and Potassium Removal: A Pilot Study
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